Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Bac... | Recruiting
Study of Radium-223 Dichloride Vers... | Recruiting
Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer

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Medical Conditions
  • Breast Neoplasms
Primary Contact Details
Bayer Clinical Trials Contact
+49 30 300139003
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02258464
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
The objective of this study is to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy.
Research Details
    Sorry, this information is not available
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Radium-223 dichloride (Xofigo, BAY88-8223), Drug : Placebo (saline), Other : Background hormonal therapy

Study Arm Groups : Radium-223 dichloride + hormonal therapy, Placebo + hormonal therapy, Radium-223 dichloride + hormonal therapy, Placebo + hormonal therapy

Intervention Type
See Interventions above
Primary Outcome Measures
    Symptomatic skeletal event free survival (SSE-FS).; From time of randomization up to 25 months
Secondary Outcome Measures
    Overall survival; From time of randomization up to 25 months; Time to opiate use for cancer pain; From time of randomization up to 25 months; Time to pain progression (only in subjects with baseline worst pain score ≤8); From time of randomization up to 25 months; Time to cytotoxic chemotherapy; From time of randomization up to 25 months; Radiological progression-free survival (rPFS); From time of randomization up to 25 months; Frequency of abnormalities in laboratory examinations.; From time of randomization up to 25 months; Pain Improvement Rate; From time of randomization up to 25 months; To measure new primary malignancies and hematopoietic reserve for tolerability of subsequent chemotherapy; From time of randomization up to 25 months
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Female
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
227
Participant Inclusion Criteria
    Inclusion Criteria:

    - Documentation of histological or cytological confirmation of estrogen receptor positive (ER+) and HER2 negative adenocarcinoma of the breast must be available.

    - Women (≥18 years of age) with metastatic breast cancer not amenable to curative treatment by surgery or radiotherapy.

    - Documentation of menopausal status: post menopausal or premenopausal subjects are eligible.

    - Subjects with bone dominant disease with at least 2 skeletal metastases identified at baseline by bone scintigraphy and confirmed by CT/magnetic resonance imaging (MRI). Presence of metastases in soft tissue (skin, subcutaneous, muscle, fat, lymph nodes)and/or visceral metastases is allowed.

    - Measurable or non-measurable disease (but radiologically evaluable) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

    - Subjects must have received at least one line of hormonal therapy in the metastatic setting

    - Subjects who are eligible for further standard of care endocrine treatment.

    - Subjects enrolled in the current study must start treatment with the single hormone agent either within 15 days prior to randomization or after randomization (before or simultaneously to the first injection of Ra-223/placebo).

    - Subjects must have experienced no more than two skeletal-related events (SREs) prior to study entry defined as: Need for external beam radiotherapy (EBRT) tor bone, pathological bone fracture (excluding major trauma), spinal cord compression and/or orthopedic surgical procedure. Subjects with no prior SREs are not permitted.

    - Subjects must be on therapy with bisphosphonate and denosumab. and are required to have been on such therapy for at least 1 month before start of study treatment.

    - Adequate hematological, liver and kidney function.

    Exclusion Criteria:

    - Subjects with Inflammatory breast cancer.

    - Subjects who have either received chemotherapy for metastatic disease or are considered by the treating investigator to be appropriate candidates for chemotherapy as current treatment for metastatic breast cancer are excluded. Chemotherapy administered for adjuvant/neo adjuvant disease is acceptable.

    - Subjects with known or history of brain metastases or leptomeningeal disease: subjects with neurological symptoms must undergo a contrast CT scan or MRI of the brain within 28 days prior to randomization to exclude active brain metastasis. Imaging of the central nervous system (CNS) is otherwise not required.

    - Known presence of osteonecrosis of jaw.

    - Patients with immediately life-threatening visceral disease, for whom chemotherapy is the preferred treatment option.

    - Lymphangitic carcinomatosis.

    - Patients with ascites requiring paracentesis within 2 weeks prior to study entry (signature of informed consent) and during the screening period.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood
England
HA6 2RN
Plymouth
PL6 8DH
Nottingham
Nottinghamshire
NG5 1PB
Coventry
CV2 2DX
Romford
Essex
RM7 0AG
Bristol
BS2 8ED
Clatterbridge Centre for Oncology NHS Trust
Birkenhead
England
CH63 4JY
Taunton
TA1 5DA
GSK Investigational Site
Cottingham
HU16 5JQ
Sheffield
S10 2SJ
The Royal Surrey County Hospital NHS Foundation Trust
Guildford
Surrey
GU27XX
Belfast
BT9 7AE
Trial Contact(s)
Primary Trial Contact
Bayer Clinical Trials Contact
+49 30 300139003
Other Trial Contacts
For more information for participation into this trial 646-776-7532 (local)
844-229-3710 (Toll free)
Countries Recruiting
Austria, Canada, China, Czechia, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Korea, Republic of, Netherlands, Norway, Poland, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride Versus Placebo When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases Treated With Hormonal Treatment Background Therapy
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
16298
Sponsor(s)
Bayer
Key Dates

Recruitment Start Date

Feb 2015

Recruitment End Date

Aug 2019

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

30 Sep 2014

Date updated in source

23 Oct 2017